# K162870: CIMLRE F1 and CIMILRE S3

- Pathway: 510(k) (Traditional)
- Applicant: Cimilre Co., Ltd.
- Decided: Mar 7, 2017 after 145 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K850705 (1985). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150476: Spectra S1Plus and Spectra S2 Plus, Uzinmedicare Co. (2016) Summary page 5.

## Most influential descendants
- K203570: Mya Joy PLUS Breast Pump (2021), 1 descendant of its own
- K223329: Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) (2023), 0 descendants of its own
- K221708: CIMILRE Free-T2 Plus (2022), 0 descendants of its own
- K212955: Fit Pro Breast Pump (2022), 0 descendants of its own

## Indications for use
The CIMILRE F1 and CIMILRE S3 are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K162870
Methodology: https://510kreport.com/methodology